12/22/2016

Securing informed consent from clinical trial participants involves more than a signature — proper understanding is key! Consent has a major impact on regulatory compliance, enrollment rates and expenses across the life of your study.

We are going through a great revolution in clinical trials to more patient centric outcomes, especially after the newly released guidance by the FDA in conjunction with the OHRP. Informed consent helps us support the patient to make knowledgeable decisions and heightens our commitment to the patients and better data collection. A paper consent is a restrictive means of delivery of this crucial information that does not support patient understanding. Additionally, paper consent limits the ability for collaboration between the site, sponsor, and ethics committee.

Electronic Informed Consent (eConsent) provides a streamlined collaboration design to save time and money in the process. Electronic Informed Consent (eConsent) offers many features related to the process of consent such as Multimedia, video, pictures and text that can make the complexity of the informed consent more manageable and accessible to a wider variety of participants. Another benefit of using electronic Informed Consent (eConsent) is its ability to support monitoring much more efficiently and timely.

The thinking is If we have better informed patients, those who accept to participate will be better participants. For more information, listen to our own SAM Sather’s opinions on eConsent in this short CRF Health’s video: